MAUDE Adverse Event Report: LUMENIS LTD PULSE; POWERED LASER SURGICAL INSTRUMENT

Model Number	GA-0006000
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ureteroscopy bilateral procedure, the console displayed error code 20 flashlamp ignition failure.The console was restarted, but the error still pops up on the screen.There were no patient complications, however, the procedure could not be completed due to this event.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
The device is not available for analysis.Therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that during a ureteroscopy bilateral procedure, the console displayed error code 20 flashlamp ignition failure.The console was restarted, but the error still pops up on the screen.There were no patient complications, however, the procedure could not be completed due to this event.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The device history record confirmed that the device met with all manufacturing specifications prior to distribution and there were no manufacturing deviations.A risk review was completed and confirmed that the event of surgical procedure delayed and cancelled/rescheduled - post sedation/sedation are defined in the risk documentation.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that during a ureteroscopy bilateral procedure, the console displayed error code 20 flashlamp ignition failure.The console was restarted, but the error still pops up on the screen.There were no patient complications, however, the procedure could not be completed due to this event.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia.

• Brand Name: PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; yokneam industrial park; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21485363
• Report Number: 2124215-2025-12231
• Device Sequence Number: 11751327
• Product Code: GEX
• UDI-Device Identifier: 07290109140544
• UDI-Public: (01)07290109140544(11)150326(10)526
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GA-0006000
• Device Catalogue Number: GA-0006000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 04/22/2025; 03/17/2026
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 05/07/2025; 04/06/2026
• Date Device Manufactured: 03/26/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male